FDA-Drug2025-01-01Class II
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01
Glenmark Pharmaceuticals Inc., USA
Hazard
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Sold states
USA Nationwide
Affected count
3,888
Manufactured in
750 Corporate Dr, Mahwah, NJ, United States
Products
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0159-2025Don't want to check this manually?
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